(38 days)
Organic Essentials Organically Grown Cotton Tampon is a tampon that is inserted into the vagina and used to absorb menstrual fluid. The intended use of the organic cotton tampon is the same as all other products that are legally marketed.
Organic Cotton Tampon
This is a letter about the clearance of the Organic Essentials Organic Cotton Tampon, a Class II medical device. The provided text is a 510(k) clearance letter and an "Indications for Use" statement.
Unfortunately, this type of document does not contain the information requested in your prompt regarding acceptance criteria, study results, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria like those described in your prompt.
Therefore, I cannot extract the requested information from the provided text.
{0}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1998 NOV
Ms. La Rhea Pepper President Organic Essentials, Inc. 822 Baldridge Street O'Donnell, TX 79351
Re: K983478
Organic Essentials Organic Cotton Tampon Dated: October 1,1998 Received: October 2,1998 Regulatory Class: II 21 CFR 884.5470/Procode: 85 HEB
Dear Ms. Pepper,
We have reviewed your Section 510K) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and . thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive. Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{1}------------------------------------------------
Page 1 of
FOA/CDRH/ODE/DMC
13 Ост 53 13 40
510(k) NUMBER (IF KNOWN): K983478
DEVICE NAME: Organic Essentials
INDICATIONS FOR USE: Organic Cotton Tampon
Organic Essentials Organically
XGrown Coton Tampon is a tampon
that is inserted into the vagina and
used to absorb menstrual
fluid.
The intended use of the organic
cotton tampon is the same as
all other products that are
legally marketed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation
Liliau Yi
(Division Sign-Off)
Prescription Use (Per 21 CFR 801.109)
Division of Reploadictive, Abdoming, ENThe - Counter and Radiological Dev (Optional Forma (k) Number
DK-55
§ 884.5470 Unscented menstrual tampon.
(a)
Identification. An unscented menstrual tampon is a device that is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual or other vaginal discharge. This generic type of device does not include menstrual tampons treated with scent (i.e., fragrance materials) or those with added antimicrobial agents or other drugs.(b)
Classification. Class II (performance standards).